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TPLC
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Device
diathermy, shortwave, for use in applying therapeutic deep heat
Product Code
IMJ
Regulation Number
890.5290
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACCELERATED CARE PLUS
SUBSTANTIALLY EQUIVALENT
1
BTL INDUSTRIES, INC
SUBSTANTIALLY EQUIVALENT
1
BTL INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
CHATTANOOGA GROUP
SUBSTANTIALLY EQUIVALENT
1
IBRAMED EQUIPAMENTOS MEDICOS
SUBSTANTIALLY EQUIVALENT
1
PROMEDTEK INC.
SUBSTANTIALLY EQUIVALENT
1
REGENESIS BIOMEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
ROCKY MOUNTAIN BIOSYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
SUBSTANTIALLY EQUIVALENT
1
VIATHERM THERAPEUTICS, LLC.
SUBSTANTIALLY EQUIVALENT
1
ZIMMER MEDIZINSYSTEME GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
5
5
2017
2
2
2019
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fire
2
2
Insufficient Information
2
2
Smoking
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Emits Odor
1
1
Device Operates Differently Than Expected
1
1
Overheating of Device
1
1
Device Inoperable
1
1
Failure to Power Up
1
1
Unexpected Therapeutic Results
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
3
3
Full thickness (Third Degree) Burn
3
3
Burn(s)
2
2
Partial thickness (Second Degree) Burn
2
2
No Known Impact Or Consequence To Patient
1
1
Injury
1
1
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DJO, LLC
II
Oct-15-2015
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